Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer’s Disease (SESAD)

The purpose of this research study is to learn more about the safety and effectiveness of a drug called sargramostim for improving cognitive function and memory in people with Alzheimer’s disease. Sargramostim is an investigational drug, meaning it has not been approved by the FDA to treat Alzheimer’s. This research study hopes to find out more about how sargramostim works within the body over a longer time period than previously studied.

Participants will be asked to participate in weekly visits for 24 weeks (6 months), as well as screening and follow-up visits. If determined to be eligible during screening, you will be assigned to one of two arms of the study: 1) receives study medication; 2) receives placebo (a pill or a liquid that looks like medicine but is not real)

These visits may include some of the following procedures:

  • Cognitive testing
  • Twice weekly blood draws
  • Heart Tracing (ECG)
  • Health Questionnaires
  • Study Partner Questionnaires
  • Lumbar Puncture (spinal tap)
  • MRI
  • PET scan
  • Treatment/placebo injection 5x a week during treatment phase

Health insurance is not needed for this study.

Elderly Asian woman receiving injection from nurse
In order to qualify you must: 

be between 60-80 years old 
have a diagnosis of mild-to-moderate Alzheimer’s disease (AD) 
be willing and able to have a lumbar puncture (spinal tap) and twice weekly blood draws
Not have a first degree relative diagnosed with AD before 55 years of age
Be willing and able to have an MRI
have a study partner willing to give daily injections after training 
Duration of Participation: Weekly appointments will be conducted at the University of Colorado Anschutz Medical Campus in Aurora, Colorado. Including screening and follow-up, study participation last up to 9-1/2 months with up to 55 visits. Screening period will last up to 8 weeks. Treatment period will last 24 weeks. Follow-up visit occurs 45 days after end of treatment
Participants will receive: Study related care and medication at no cost. Compensation Provided.

To learn more, please contact us at 303-724-4644 or NeuroResearch@cuanschutz.edu or fill out the research inquiry form at www.cumemoryresearch.org

SESAD Flyer

SESAD Catalog Pages